We are currently seeking a Director, GMP Quality Assurance. This individual will have responsibility for the operational management of Commercial GMP QA activities within Agios. This includes commercialization of Agios’ phase III program within US and Europe. The Director will have responsibility for leading a team that provides GMP quality and compliance oversight of commercial launch activities, manufacturing, packaging, labeling, release and distribution activities performed by Contract Development/Manufacturing Organizations (CDMOs). The Director is responsible for oversight of department activities, development of personnel and ensuring quality of deliverables within their scope. The Director is recognized as an expert in the principles and application of quality assurance and compliance; and will work to continuously improve GMP processes and to support the state of commercial GMP compliance at Agios. The Director is responsible for maintaining strategic group goals and development of project goals ensuring alignment with corporate goals and compliance with all regulatory requirements. This individual will report to the Senior Director, GMP Quality Assurance.
Provide leadership and strategic direction to a team of GMP QA personnel responsible for GMP activities for products in Phase III through commercial.
Responsible for providing quality oversight and support to all commercial programs; support of external development and manufacturing activities at CDMOs across all phases of development for raw materials, drug substance, drug product and finished marketed product.
Manage direct reports, provide leadership, mentorship and direction.
Provide onsite oversight/monitoring of manufacturing campaigns as appropriate.
Coordinate commercial QP release as appropriate.
Support all global commercial packaging validation, mock launch and product launch activities, including PI proofreading.
Oversight of secondary sourcing Drug Substance and Drug Product process validation activities.
Assist in preparing or reviewing CMC sections of regulatory submissions and collaboration on regulatory responses.
Responsible for regulatory submission and response QA document audits.
Manage and address associated internal and external deviations, Investigations, CAPAs, Change Controls, Material Review Boards, product complaints, OOS, risk assessments, etc.
Provide direction and guidance to personnel during handling and resolution of quality events.
Responsible for oversight of CDMO performance, establishment of Quality Agreements and adherence of Quality Agreement terms.
Ensure CDMOs and other GMP service providers are compliant in accordance with Agios vendor management program.
Ensure CDMO and commercial product metrics are established, tracked, and communicated to facilitate continuous improvements.
Represent the QA department on project teams.
Conduct internal audits as necessary.
Assist in company preparations for and conduct of regulatory inspections.
Responsible for developing and maintaining compliant quality processes to support GMP activities.
Effectively interact with external contract manufacturers and testing laboratories as well as work as part of an internal multidisciplinary team.
Support Computer System Validation activities, as required, including commercial inventory system validation.
Bachelor’s degree in biology, chemistry, life sciences or a related field. 10-15+ years of direct Quality Assurance experience in a pharmaceutical cGMP environment. Commercial experience preferred.
Strong knowledge of cGMP regulations, practices and trends pertaining to commercial manufacturing, packaging, labeling and distribution within the pharmaceutical industry.
Exercises judgment within broadly defined practices and policies in determining solutions and actions.
Experience in launch activities and process validations strongly preferred.
Demonstrates ability to identify and recognize quality issues that will result in critical delays in schedule or operations and may jeopardize overall business activities.
Knowledge of drug substance, drug product, finished goods; and solid dosage manufacturing principles, equipment and processes.
Experience working with CMOs preferred.
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